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Delay in Forest Drug FDA Action Date

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Forest Laboratories, Inc. will be facing a delay where the approvability status of one of its pipeline candidates is concerned. The company recently announced that the US Food and Drug Administration (FDA) has extended its action date for aclidinium bromide by three months.

Forest Labs and partner Almirall are looking to get aclidinium bromide approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

We note that last month, aclidinium bromide had received a positive recommendation from the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC). The committee voted 12 to 2 in favor of approving aclidinium bromide for the maintenance treatment of COPD. The committee also voted unanimously in favor of the efficacy and 10-3 in favor of the safety of the 400 ug twice daily dose.

With the FDA pushing out the action date by three months, a response regarding the approvability of the candidate should now be out by July. The agency has not asked for additional data.

Forest Labs currently has another candidate, linaclotide, under FDA review. Linaclotide, which is partnered with Ironwood Pharmaceuticals (IRWD - Free Report) , is under review for the treatment of constipation-predominant irritable bowel syndrome and chronic constipation. A response on linaclotide should be out in June 2012.

Forest Labs needs to build its portfolio as the company is facing a major patent cliff now that its key revenue generator, Lexapro, is facing generic competition. While Teva (TEVA - Free Report) launched its generic version of Lexapro recently, Mylan (MYL - Free Report) is marketing an authorized generic version of the product.

Moreover, Forest Labs’ Namenda will face generic competition in early 2015 putting another $1+ billion at risk. That puts a lot of pressure on the pipeline to come through.

We currently have a Neutral recommendation on Forest Labs.

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